Trial Outcomes & Findings for B. Lactis HN019 for Functional Constipation (NCT NCT01463293)
NCT ID: NCT01463293
Last Updated: 2014-07-24
Results Overview
The primary endpoint of this clinical trial is whole gut transit time, which will be assessed using abdominal x-rays on days 0 and 28
COMPLETED
PHASE3
224 participants
4 weeks
2014-07-24
Participant Flow
Participant milestones
| Measure |
High-dose Probiotic
Capsule containing 10 billion cfu B. lactis HN019
B. lactis HN019: Capsule containing 10 billion cfu B. lactis HN019 once a day
|
Low Dose Probiotic
Capsule containing 1 billion cfu B. lactis HN019
B. lactis HN019: Capsule containing 1 billion cfu B. lactis HN019 once a day
|
Placebo
Placebo capsule
Placebo: Capsule containing no probiotic once a day
|
|---|---|---|---|
|
Overall Study
STARTED
|
74
|
79
|
71
|
|
Overall Study
COMPLETED
|
68
|
63
|
59
|
|
Overall Study
NOT COMPLETED
|
6
|
16
|
12
|
Reasons for withdrawal
| Measure |
High-dose Probiotic
Capsule containing 10 billion cfu B. lactis HN019
B. lactis HN019: Capsule containing 10 billion cfu B. lactis HN019 once a day
|
Low Dose Probiotic
Capsule containing 1 billion cfu B. lactis HN019
B. lactis HN019: Capsule containing 1 billion cfu B. lactis HN019 once a day
|
Placebo
Placebo capsule
Placebo: Capsule containing no probiotic once a day
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
5
|
|
Overall Study
Adverse Event
|
1
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
10
|
5
|
|
Overall Study
Other
|
0
|
0
|
2
|
Baseline Characteristics
B. Lactis HN019 for Functional Constipation
Baseline characteristics by cohort
| Measure |
High-dose Probiotic
n=74 Participants
Capsule containing 10 billion cfu B. lactis HN019
B. lactis HN019: Capsule containing 10 billion cfu B. lactis HN019 once a day
|
Low Dose Probiotic
n=79 Participants
Capsule containing 1 billion cfu B. lactis HN019
B. lactis HN019: Capsule containing 1 billion cfu B. lactis HN019 once a day
|
Placebo
n=71 Participants
Placebo capsule
Placebo: Capsule containing no probiotic once a day
|
Total
n=224 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.3 years
STANDARD_DEVIATION 12.1 • n=99 Participants
|
42.9 years
STANDARD_DEVIATION 12.0 • n=107 Participants
|
41.1 years
STANDARD_DEVIATION 12.6 • n=206 Participants
|
41.8 years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
161 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
63 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Caucasian, non-Hispanic
|
27 participants
n=99 Participants
|
35 participants
n=107 Participants
|
26 participants
n=206 Participants
|
88 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 participants
n=99 Participants
|
2 participants
n=107 Participants
|
6 participants
n=206 Participants
|
12 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
17 participants
n=99 Participants
|
11 participants
n=107 Participants
|
11 participants
n=206 Participants
|
39 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
2 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
African-American, Black
|
19 participants
n=99 Participants
|
25 participants
n=107 Participants
|
24 participants
n=206 Participants
|
68 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 participants
n=99 Participants
|
5 participants
n=107 Participants
|
4 participants
n=206 Participants
|
15 participants
n=7 Participants
|
|
Region of Enrollment
United States
|
74 participants
n=99 Participants
|
79 participants
n=107 Participants
|
71 participants
n=206 Participants
|
224 participants
n=7 Participants
|
|
Height, M
|
1.66 M
STANDARD_DEVIATION 0.12 • n=99 Participants
|
1.68 M
STANDARD_DEVIATION 0.09 • n=107 Participants
|
1.68 M
STANDARD_DEVIATION 0.10 • n=206 Participants
|
1.68 M
STANDARD_DEVIATION 0.10 • n=7 Participants
|
|
Weight, Kg
|
74.9 Kg
STANDARD_DEVIATION 15.2 • n=99 Participants
|
77.5 Kg
STANDARD_DEVIATION 15.9 • n=107 Participants
|
74.3 Kg
STANDARD_DEVIATION 14.9 • n=206 Participants
|
75.6 Kg
STANDARD_DEVIATION 15.0 • n=7 Participants
|
|
BMI
|
27.0 Kg/m^2
STANDARD_DEVIATION 4.2 • n=99 Participants
|
27.4 Kg/m^2
STANDARD_DEVIATION 4.4 • n=107 Participants
|
26.6 Kg/m^2
STANDARD_DEVIATION 4.7 • n=206 Participants
|
27.0 Kg/m^2
STANDARD_DEVIATION 4.4 • n=7 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: Only 39 out of the 224 enrolled subjects consumed the radio-opaque markers in line with the protocol. Because of the substantial number of protocol deviations and the lack of sufficient evaluable subjects, no further analyses of the study data were performed. The study appears not to have yielded evaluable data.
The primary endpoint of this clinical trial is whole gut transit time, which will be assessed using abdominal x-rays on days 0 and 28
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeksThe PAC-SYM tool asks 12 questions on the symptoms of constipation. Subjects will complete the PAC-SYM at days 0 and 28.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeksThe PAC-QoL is a 28-question survey that asks questions on their quality of life.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeksThe Bowel Function Index is a 3-question tool that asks subjects if they have experienced adequate relief of constipation symptoms over the past week. The Bowel Function Index will be completed at days 0 and 28.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeksAdequate relief of constipation (yes/no) This (yes/no) questionnaire will be completed at days 0 and 28.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeksSubjects will record the number of defecations per day in a diary.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeksStool consistency will be rated each day in a diary by using the Bristol Stool Scale Form
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeksAt the end of the supplementation period, subjects will be asked to rate their overall satisfaction with the study product's ability to relieve their constipation symptoms on a 5-point ordinal scale
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeksAll adverse events, regardless of relationship with investigational product, will be reported during the 4-week follow-up period.
Outcome measures
Outcome data not reported
Adverse Events
High-dose Probiotic
Low Dose Probiotic
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
High-dose Probiotic
n=74 participants at risk
Capsule containing 10 billion cfu B. lactis HN019
B. lactis HN019: Capsule containing 10 billion cfu B. lactis HN019 once a day
|
Low Dose Probiotic
n=79 participants at risk
Capsule containing 1 billion cfu B. lactis HN019
B. lactis HN019: Capsule containing 1 billion cfu B. lactis HN019 once a day
|
Placebo
n=71 participants at risk
Placebo capsule
Placebo: Capsule containing no probiotic once a day
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal discomfort
|
4.1%
3/74
|
5.1%
4/79
|
7.0%
5/71
|
|
Respiratory, thoracic and mediastinal disorders
Respriatory symptoms
|
6.8%
5/74
|
2.5%
2/79
|
1.4%
1/71
|
|
General disorders
Headache
|
1.4%
1/74
|
5.1%
4/79
|
4.2%
3/71
|
|
General disorders
Injury
|
1.4%
1/74
|
0.00%
0/79
|
4.2%
3/71
|
|
General disorders
Other
|
9.5%
7/74
|
7.6%
6/79
|
11.3%
8/71
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60